Investigators are required to report to the WVDE IRB any adverse events that result in unanticipated problems during the course of their research. Guidance from OHRP defines an unanticipated problem as any incident, experience or outcome that meets all of the following criteria:
Investigators are responsible for reporting all adverse events that result in unanticipated problems immediately. The principal investigator must notify the IRB within 24 hours and then complete an IRB Adverse Event Reporting Form and submit it directly to the IRB Secretary and Chair for documentation.
The IRB Adverse Event Reporting Form requires a detailed description of the event, incident, experience, or outcome, an explanation of the basis for determining that the event, incident, experience, or outcome represents an unanticipated problem, and a description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem. The IRB also requires the principal investigator to submit any supporting documentation which illustrates the changes that have taken place (e.g., sample consent forms/data collection instruments).
|IRB Adverse Event Reporting Form||Must be submitted within 24 hours of the event's occurrence|
|Supporting Documentation||e.g., revised consent forms, data collection instruments, etc.|
There are serious consequences for not reporting adverse events in a timely manner. Always report these events immediately.